A Study of the Effects of PEITC on Oral Cells With Mutant p53

The aim of this clinical trial is to examine the effects of phenethyl isothiocyanate (PEITC), a compound derived from cruciferous vegetables, on oral cells with mutant p53. The p53 protein's normal (wild-type) function within cells is to act as a tumor suppressor, or anti-cancer protein. When mutated, the p53 protein not only no longer executes the functions of a tumor suppressor, and it can gain functions as a pro-cancer protein.22 The proposed clinical trial will utilize oral cells collected from subjects who are heavy smokers. Since the subjects are regularly exposed to mutagenic chemicals it is the thought that their oral cells will contain measurable levels of mutant p53. The participants will consume watercress juice, which is rich in PEITC (See Figure 1). Previous studies in the laboratory showed PEITC selectively depletes mutant p53, and not wild type p53, in cell culture. Our hypothesis is that the ITC in the watercress juice will lead to the depletion of mutant p53 within the oral cells. This depletion could lead to a possible clinical application of this compound, such as chemopreventives or oncologic treatments of individuals with oral cancers.

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Key information

Conditions

Oral Cancer Head and Neck Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Stomatognathic Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Georgetown Clinical Research Unit

Washington D.C., District of Columbia, 20007, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Heavy Smoker
Between the ages of 20 and 65
Must be able to show proof of citizenship or residency of the United States
Able to sign and understand a standard consent form

Exclusion criteria

Pregnant or Breast-feeding
Having any of the following medical conditions:
Leukoplakia
Oral Lesions
Cancer
Any oral disease that causes sores, ulcerations, irritations, etc.
Stomach or Intestinal Ulcers
IBS (Irritable Bowel Syndrome)
Kidney Disease
Allergies to watercress or other Cruciferous Vegetables
Strict Vegetarians or Vegans
Religious Consumers of Watercress or other Cruciferous Vegetable Juices
On any of the following medications:
Chlorzoxazone (Parafon Forte, Paraflex)
Lithium
Water Pills/Diuretics (Thiazide or Lasix)
Warfarin (Coumadin)
Vitamin K supplements
H2 acid blocker (Zantac, Pepcid, Axid, Tagamet)
Proton Pump Inhibitor (Prevacid)
Digoxin
Antibiotics
Diabetic Medications (Insulin)
Inhaled Bronchodilator
Oral Steroids (Prednisone, Medrol)
Inhaled Steroids (Flonase)
Raloxifene or Tamoxifen
Thyroid Hormone Replacement

Treatment and study plan

Watercress Juice

Dietary Supplement

The juice is prepared, by a trained member of the Chung laboratory staff, in the following manner; each serving of watercress juice will be prepared with 55gm watercress (from a local grocery store) with 220 ml purified water, for a proportion of 1:4 (w/w). The watercress and water will be placed in a 1.5 L mechanical blender and blended at low speed for approximately 15 seconds, followed by blending at a high speed for one additional minute. The resulting suspension will be filtered through two layers of cheese cloth. Remaining liquids will be manually extracted from the cheese cloth into the same container. Each serving will be measured to 200 ml. The remaining 20 ml will be used for analysis of ITC content. Each serving will be prepared and kept at 40 C until needed, no more than one hour prior to participant consumption by the subject.

Primary outcomes

Evidence of reduced number of oral cells with mutant p53 after administration of PEITC derived from watercress, a cruciferous vegetable.

Time frame: 8 hours

Sponsors and collaborators

Lead sponsor

Georgetown University

Other

Registry information

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Feb 13, 2013
Registry last updated: Mar 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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